Job Title: Senior Clinical Trial Associate (Sr. CTA) – TMF/eTMF Specialist (US Healthcare Trials)
Company: Hvantage Tech Solutions Pvt. Ltd.
Location: Remote / Hybrid (India)
Working Hours: 6:30 PM – 3:00 AM IST (US Time Zone Overlap)
Employment Type: Full-Time
Experience Required: 5+ Years
Domain: Clinical Research / US Healthcare / Biotech / Pharma
About Hvantage Tech Solutions Pvt. Ltd.
Hvantage Tech Solutions Pvt. Ltd. is a global provider of technology-driven healthcare and life sciences solutions, supporting clinical trials, healthcare data platforms, and regulatory compliance initiatives for clients across the US and global markets. We specialize in enabling high-quality, compliant, and scalable clinical operations through deep domain expertise and advanced technology integration.
Position Overview
We are seeking a highly experienced Senior Clinical Trial Associate (Sr. CTA) with a strong focus on TMF/eTMF management, documentation quality, and regulatory compliance.
This role is documentation-intensive and quality-critical, requiring:
- Deep hands-on experience in TMF/eTMF operations
- Strong understanding of ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate)
- Expertise in upload, QC (Quality Control), metadata handling, and inspection readiness
- Ability to work effectively in non-standard or homegrown document management systems
The ideal candidate will have prior experience in small to mid-size biotech environments, where:
- Documentation is often decentralized
- Systems may not be standardized (e.g., non-Veeva environments)
- Greater ownership and critical thinking is required
Key Responsibilities
1. TMF / eTMF Management & Ownership (CORE RESPONSIBILITY)
- Own and manage the Trial Master File (TMF/eTMF) across all clinical trial phases.
- Perform end-to-end TMF activities, including:
- Document upload
- Quality Control (QC)
- Indexing
- Metadata tagging
- Version control
- Ensure compliance with:
- ICH-GCP
- FDA 21 CFR Part 11
- ISO 14155
- Apply ALCOA principles rigorously to all documentation activities.
- Maintain continuous inspection readiness:
- Identify missing documents
- Resolve discrepancies proactively
- Maintain audit trails
2. TMF Reconciliation-
- Conducted periodic reconciliation of the Trial Master File (TMF) against expected document lists to ensure completeness and regulatory compliance.
- Cross-checked TMF contents with study trackers, vendor deliverables, and site documentation to identify missing, duplicate, or inconsistent records.
- Collaborated with cross-functional teams (Clinical Operations, CROs, and vendors) to resolve discrepancies and ensure timely document filing.
- Maintained reconciliation logs and generated reports highlighting gaps, risks, and corrective actions.
- Ensured alignment of TMF documents with regulatory requirements such as ICH-GCP and internal SOPs.
- Supported inspection readiness by ensuring TMF completeness and audit traceability.
3. TMF Quality Control (QC)
- Performed quality control (QC) reviews of TMF documents to ensure accuracy, completeness, and compliance with applicable SOPs and regulatory standards.
- Verified document metadata, indexing, version control, and proper filing within the eTMF system.
- Identified and flagged quality issues such as incorrect document types, missing signatures, or incomplete records.
- Ensured consistency in naming conventions, formatting, and classification of TMF artifacts.
- Coordinated with document owners to resolve QC findings and ensure timelyclosure.
- Contributed to continuous improvement initiatives by identifying recurring QC issues and recommending process enhancements.
4. Document Quality Review & Critical Thinking
- Conduct in-depth QC reviews of TMF documents, ensuring:
- Accuracy
- Completeness
- Compliance with study protocols
- Evaluate documentation for:
- Logical consistency
- Regulatory alignment
- Data integrity risks
- Apply critical thinking to identify:
- Gaps in documentation
- Inconsistent metadata
- Misaligned records across systems
- Collaborate with cross-functional teams to resolve quality issues proactively
5. Working with Homegrown / Non-Standard Systems
- Effectively manage documentation within custom-built or decentralized systems
- Adapt to environments where:
- Documentation is distributed across multiple repositories
- Standardized tools like Veeva Vault may not be used
- Ensure consistency, traceability, and compliance across systems
- Develop internal processes and best practices to improve documentation quality
6. Clinical Documentation Management
- Prepare, review, and maintain key trial documents:
- Protocols
- Informed Consent Forms (ICFs)
- Case Report Forms (CRFs)
- Clinical Study Reports (CSRs)
- Manage document lifecycle:
- Creation → Review → Approval → Archival
- Ensure proper document classification and indexing
7. Regulatory Compliance & Audit Readiness
- Ensure adherence to:
- GCP, FDA, EMA, and ISO standards
- Support:
- Regulatory submissions
- Inspection readiness activities
- Prepare for and assist in:
- Internal audits
- External inspections (FDA/EMA)
- Implement and track CAPA (Corrective and Preventive Actions)
8. Site Coordination & Communication
- Coordinate with:
- Clinical sites
- Investigators
- Sponsors
- Support:
- Site Initiation Visits (SIV)
- Monitoring visits
- Close-out activities
- Act as a primary documentation liaison across stakeholders
9. Metadata Management & Data Integrity
- Ensure accurate and consistent:
- Metadata tagging
- Document categorization
- Maintain strong data governance practices
- Identify and resolve:
- Metadata inconsistencies
- Document duplication issues
10. Reporting & Analytics
- Track TMF health metrics:
- Completeness
- Timeliness
- Quality scores
- Generate reports using:
- Advanced Excel (PivotTables, macros)
- Internal dashboards
- Provide insights to leadership on:
- Documentation quality trends
- Compliance risks
11. Risk Identification & Problem-Solving
- Identify risks related to:
- Documentation gaps
- Regulatory non-compliance
- Data inconsistencies
- Perform root cause analysis and implement solutions
- Proactively mitigate risks before audits
Required Qualifications
Education
- Bachelor's degree in:
- Life Sciences / Health Sciences / Nursing / Pharmacology or related field
- GCP Certification (Mandatory)
Experience
- Minimum 5+ years of experience in:
- Clinical trial documentation
- TMF/eTMF management
- Strong hands-on experience with:
- TMF upload & QC processes
- Inspection readiness
- Metadata management
- Experience working in:
- Small to mid-size biotech organizations (highly preferred)
Technical Skills
- TMF/eTMF systems (Veeva Vault preferred, but NOT mandatory)
- Experience working in non-standard/homegrown systems
- CTMS / EDC tools:
- Medidata RAVE
- Oracle Inform
- Advanced Excel
- SharePoint / document collaboration tools
Core Competencies (CRITICAL)
✔ Deep understanding of ALCOA principles
✔ Strong attention to detail
✔ Exceptional documentation quality mindset
✔ Strong analytical & critical thinking skills
✔ Ability to work independently in decentralized environments
✔ Strong communication & stakeholder management
Preferred Qualifications
- Experience in US clinical trials
- Exposure to:
- FDA inspections
- EMA audits
- Experience with:
- Medical device trials
- Biotech / early-stage companies
- Knowledge of:
- Regulatory submission processes (IDE, PMA)
Work Environment & Expectations
- Work in US time zone overlap (6:30 PM – 3:00 AM IST)
- High accountability for documentation quality and compliance
- Fast-paced, cross-functional collaboration
- Ability to work independently with minimal supervision
Impact of the Role
This role is mission-critical as:
- TMF errors can directly impact:
- Trial approvals
- Regulatory compliance
- Patient safety
- You will be responsible for ensuring audit-ready documentation at all times
Why Join Hvantage -
- Work on global clinical trials with US clients
- Exposure to cutting-edge healthcare & biotech environments
- Opportunity to work in high-impact, compliance-critical roles
- Growth into:
- Clinical Operations Lead
- TMF Specialist Lead
- Regulatory Affairs roles
